(65 days)
The Hewlett Packard External electrodes are indicated for use in external Pacing, Defibrillation and Monitoring applications as a non-sterile, disposable, single patient use, only. The M3501A & M3502A electrodes provide the conductive interface between and the defibrillator and/or the external pacing instrument. This device is intended for use on adult patients.
When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose classified as low power (360 Joule maximum.)
Multifunction Adult Defib. Electrodes Model Numbers M3501A/M3502A
The provided text is a 510(k) premarket notification approval letter for the Hewlett Packard M3501A/M3502A Multifunction Adult Defibrillator Electrodes. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
The letter acknowledges the device's substantial equivalence to legally marketed predicate devices and outlines general regulatory compliance requirements. It details the device's indications for use: "external Pacing, Defibrillation and Monitoring applications as a non-sterile, disposable defibrillator and/or external pacing electrode." It specifies that the electrodes are for "single patient use, only" and "intended for use on adult patients," connecting to "defibrillators whose stored energy is classified as low power (360 Joule maximum)."
Therefore, I cannot provide the requested information based on the input text. The document is an FDA approval letter, not a study report.
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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three wing segments, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 5 1999
Mr. Warren R. Walters Hewlett Packard Company c/o Katecho, Inc. 2500 Bell Avenue Des Moines, IA 50321
K991871
Multifunction Adult Defib. Electrodes Model Numbers M3501A/M3502A
Multifunction Adult (three) Re: Murcilanov Class: III (three) Product Code: 73 MLN May 28, 1999 Dated: Received: June 1, 1999
Dear Mr. Walters:
We have reviewed your Section 510 (k) notification of intent to market We have reviewed your Section July have determined the device is the device referenced above and we nave decoraner as a
substantially equivalent (for the indications for use stated in substantially equivalent (for the indicate devices marketed in
enclosure) to legally marketed predicate devices date enclosure) to legally marketed programs and comment date of the interstate commerce prior to May 20, 1970, cho been reclassified
Medical Device Amendments, or to devices that have been Food, Drug, and Medical Device Amendments, Of Co Geviews Food, Drug, and in accordance with the provisions of the rederal room and of the productions of the country of the device, subject to
controls and the provisions of the Act. The general cont Cosmetic Act (Act). You may, the Act. The general controls the general controls provisions of the Act. Inc. general registration,
provisions of the Act include requirements for annual registration, and provisions of the Act include requirements research and listing of devices, good manufacts.
prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special If your device is classified (see above) incoles subject to such Controls) or class III (Permarket Applovar); ic maj as
additional controls. Existing major regulations affecting your device additional controls. Existing mayor regardisons, Title 21, Parts 800
can be found in the Code of Federal Regulant ion assumes compliance can be found in the Code of rederal nation assumes compliance
to 895. A substantially equivalent determination assumes as set to 895. A substantially equivaries actoring Practice requirements, as set
with the Current Good Manufacturing USS for Medical Devices: with the Current Good Manufaccaring read for Medical Devices:
forth in the Quality System Regulation (QS) for Medical periodic forth in the Quality System Regulation (go) bod that, through periodic QS
General regulation (21 cERR Part Administration (FDA) will verify success General regulation (2) CPR Parc ozo) and chao, estato, (FDA) will verify such inspections, the Food and Dray Aumin Bor regulation may result in assumptions. Failure to compul with the culture announcements
regulatory action. In addition, FDA may publish first announcements regulatory action. In addiction concerning your device in the rederal noglession does not affect any
response to your premarket notification submission does of the Act response to your premarket incrirections 531 through 542 of the Act
obligation you might have under sections Control provision obligation you might have under Sections 351 chirage of the movisions,
for devices under the Electronic Product Radiation Control provisions,
for devices under the Electronic or other Federal laws or regulations.
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Page 2 - Mr. Warren R. Walters
This letter will allow you to begin marketing your device as described.
The FM BAND worserker potification. The FDA finding of substantial This letter will allow you to begin market.ng your acvase .
in your 510 (k) premarket notification. The FDA finding of substantial in your 510(k) premarket notification. The first your your your be er in a classification for your device and thus, permits your comments.
results in a classification for your device and thus, permits your results your results your results y results in a crabbilly.
device to proceed to the market.
If you desire specific advice for your device on our labeling If you desire specific advice for your device on on for in vitro regulation (21 CFR Part 801 and additionally 1631 of Compliance at
diagnostic devices), please contact the Office of Compliance at diagnostic devices), please contact the office of on the promotion and (201) 594-468. Additionaly, for questions on the promosours at
(201) 594-468. Additionaly, for questions of Compliation entitled, at enti advertising of your device, please concacion entitled,
(301) 594-4639. Also, please note the regulation (21 CFR (301) 594-4639. Also, please note the regulacion cultures and .
"Misbranding by reference to premarket notification" (21 CFR 807.97) . "Misbranding by reference to premarket notification (as may may
Other general information on your responsibilities under the act may Other general information on your responsibilities and its
be obtained from the Division of Small Manufacturers Assistance at its internet be obtained from the Division of Small Malluraced Cromann Collection
toll-free number (800) 638–2041 or (301) 443–6597, or at its internet
s (1) (1) (1) (1) (1) (1) = 5de =6x toll-free number (800) 656-2041 Of (803)
address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Cullerton
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Vision of Cardiovaoorological Devices - Respiratory, Device Evaluation Center for Devices and Radiological Health
で
Enclosure
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Indications for use Statement
not assigned 510k Number:
"Hewlett Packard M3501A & M3502A Multifunction Defib Electrodes" Device Name:
Indications For Use:
The Hewlett Packard External electrodes are indicated for use in external Pacing, Defibrillation and The Howlet Packard External electrodes are interess sigle patient use, only. The M3501A & Monitoring applications as a non-sterne, disposable defibrillator and/or the external M3502A electrodes provide the conductive interrace between and the electrode is intended for use on adult patients.
When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to When a patient requires delibrilation, caldioveision or external promogy.
the patient and connected to the instrument. This device is intended for use on defibrillators whose classified as low power (360 Joule maximum.)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR Over-The Counter Use ______________________________________________________________________________________________________________________________________________________ Prescription Use > (Per 21 CFR 801.109)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 870.5310 Automated external defibrillator system.
(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.